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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3847

2. Registrant Information.

Registrant Reference Number: 2015CK274

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 Matheson Boulevard

City: Missisaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

05-AUG-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

11-NOV-13

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 1556-155

Product Name: Seresto Collar - small dog

  • Active Ingredient(s)
    • Flumethrin
    • IMIDACLOPRID
      • Guarantee/concentration 10 %

7. b) Type of formulation.

Other (specify)

Collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On 24-Oct-2013, a (age) year old, unknown height and weight, female, human, in fair condition with known concomitant medical conditions of allergies and diabetes, was exposed to 1 Seresto Small Dog collar (Flumethrin-Imidacloprid) that had been placed around the neck of the dog by the Veterinarian.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Female

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Gastrointestinal System
    • Symptom - Nausea
  • Cardiovascular System
    • Symptom - Tachycardia
  • Eye
    • Symptom - Blurred vision

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

Yes

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Other

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

On 11-Nov-2013 the collar broke at an unknown point on the collar and fell off the dog. got a powder on her hands. The individual washed her hands. Approximately 5 minutes after the powder was on her hands she was nauseated, had blurred vision and her heart was racing.She was transported by ambulance to a hospital and the clinical signs continued.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

O - Unclassifiable/unassessable. Direct product exposure occurred when collar broke and patient touched the collar. However, exposed hands were washed. Systemic signs would not be expected with exposure of product to hands. Reported cardiologic, ocular and digestive signs are not expected after contact the collar. This elderly patient was in fair condition with known concomitant medical conditions of allergies and diabetes prior to product exposure, which might have contributed to the reaction. The very short onset time rather suggests an anxiety reaction as signs not in line with an anaphylactic reaction. In the end, a connection to the product is deemed to be not assessable.Initial assessment confirmed by medical doctor.